Product Surveillance Engineer - (Medical Device Quality) Job

Yoh has an excellent contract opportunity for a PRODUCT SURVEILLANCE ENGINEER to join our client in Totowa, NJ.

JOB RESPONSIBILITIES:

- The Product Surveillance Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices.
- The Product Surveillance Engineer is responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business.
- Key contributor as part of a complaint handling unit
- Developing and implementing methods and procedures for effective trending of complaints
- Facilitating complaint investigation
- Engaging product design owners to determine effective CAPA
- Identifying complaints that represent further evaluation under 21CFR Part 803 (MDR)
- Reviewing appropriate criteria for closure of complaints
- Owning and communicating metrics on status

Job Qualification:

- Bachelor's degree in Engineering and two (2) years of experience in Medical Device Quality engineering or product surveillance.
- Product-specific knowledge
- Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level productsproductionCorrective & Preventive Action (CAPA), complaints& product quality improvement using tools such as six sigma, DFR, etc.
- Demonstrated knowledge of 21CFR Part 820
- Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment
- Ability to work independentlyvisit our website to learn both about our company and about our leading professional staffing solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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